None listed
Conditions
Interventions
Medical Device : The experimental group will receive 650nm laser therapy using the Ellise medical laser device (manufactured by Wontech Co., Ltd.), while the control group will undergo microcurrent el
Sponsors
Dongshin University Gwangju Oriental Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Participants will be included if they meet all of the following criteria: Participants aged between 19 and 70 years Those with nonspecific chronic low back pain persisting for more than three months and experiencing pain for at least 14 days per month during the three months prior to screening Participants with moderate low back pain, defined as a 100mm Visual Analog Scale (VAS) score between 35 and 74 at screening Those with no difficulty in reading and understanding Korean Participants who voluntarily sign the written informed consent for study participation
Exclusion criteria
Exclusion criteria: Participants will be excluded if they meet any of the following criteria: 1. Radiculopathy or neurological deficits associated with low back pain, including radiating pain to the lower limbs 2. Severe spinal conditions, such as malignant tumors, recent compression fractures, spinal infections, or cauda equina syndrome 3. Serious comorbidities, including cancer, advanced renal, hepatic, cardiovascular, or neurological diseases, as well as diabetic neuropathy 4. History of substance abuse(including alcohol) or psychiatric disorders, including dementia, schizophrenia, epilepsy, or depression requiring treatment within the past six months 5. Other musculoskeletal or systemic conditions that may contribute to low back pain, such as trauma, ankylosing spondylitis, fibromyalgia, rheumatoid arthritis, or gout 6. Contraindications to invasive laser acupuncture, including bleeding disorders, severe skin conditions at the treatment site, implanted metallic devices in the lumbar region, or use of implantable electronic medical devices (e.g., pacemakers) 7. Moderate to severe depression, defined as a Beck Depression Inventory-II (Korean version) score of 23 or higher 8. History of lumbar surgery within the past year or a scheduled procedure 9. Pregnancy or plans to conceive during the study period 10. Concurrent participation in another clinical trial 11. Legal or compensation-related treatment for low back pain 12. Any condition deemed inappropriate for study participation by the principal investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the difference in Visual Analog Scale score changes | — |
Secondary
| Measure | Time frame |
|---|---|
| the difference in Visual Analog Scale score changes;the difference in the proportion of responders between the experimental and control groups;the change in Oswestry Low Back Disability Questionnaire scores;the change in European Quality of Life Five Dimension Five Level Scale scores | — |
Countries
Korea, Republic of
Contacts
Public ContactJae Hong Kim
Dongshin University
Outcome results
None listed